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We read the recent article by Slade et al1 with great interest and agree that reasonable regulation focused on the development and appropriate evaluation of potential reduced risk cigarettes is warranted. Furthermore, we agree with Slade et al that the results of our evaluation indicate that Eclipse may offer potential benefits to smokers. However, we disagree with several of the other conclusions drawn by the authors.
The article challenges the merits of Eclipse and questions the fundamental differences between Eclipse and other cigarettes. It is not possible within the context of this letter either to fully describe the scientific data that has been developed to characterise Eclipse or to address many of the criticisms of Eclipse raised in Slade’s article. However, we briefly address pertinent issues below and encourage interested parties to independently evaluate all of the available information.
Slade et al have inaccurately represented the claims that RJ Reynolds Tobacco Company (RJRT) has made regarding Eclipse. No cigarette is without risk, including Eclipse. Our advertising for Eclipse states: “The best choice for smokers who worry about their health is to quit. But Eclipse is the next best choice for those who have decided to continue smoking.” Our advertising also makes it clear that RJRT does not claim that Eclipse presents less risk of cardiovascular disease or complications with pregnancy.
In the absence of any existing regulatory standard, RJRT assessed Eclipse’s risk reduction potential using a four step scientific methodology that included chemical testing and analysis, biological and toxicological testing, human testing, and independent scientific verification. In general, the evaluation strategy utilised was consistent with strategies outlined by the Institute of Medicine Committee that addressed this subject.2 RJRT has conducted an extensive comparative evaluation of Eclipse and has presented this research at scientific meetings in the both the USA and internationally. The results of these and other studies may be reviewed on the Eclipse website (www.eclipsescience.com).
In addition, much of this research has been published in the peer reviewed literature. The weight of the evidence from this research clearly shows that, compared to other cigarettes, Eclipse may present smokers with less risk of cancer, chronic bronchitis, and possibly emphysema. An independent panel of scientific experts reviewed the science and reached conclusions consistent with RJRT’s claims.3
RJRT’s comparative studies were conducted using Kentucky reference cigarettes (K1R5F and K1R4F) and leading low “tar” and ultra low “tar” commercial brand styles. Combined, the cigarettes selected for comparison to Eclipse are representative of the vast majority of cigarettes sold in the US market.4–6 By contrast the entire market segment of the very low yielding ultra low “tar” cigarettes used by Slade et al as a comparison collectively represent less than 1% of the market. Furthermore, one of the two cigarettes selected as a comparison (Now Box) does not have a measurable US Federal Trade Commission (FTC) “tar” yield.
Comparisons of Eclipse mainstream smoke constituent yields to the yields of very low yielding ultra low “tar” cigarettes (Now Box and Carlton Soft Pack) obtained by machine smoking do not change the fact that an extensive battery of scientific tests indicates that Eclipse cigarettes may present smokers with less risk of certain smoking related diseases than other cigarettes. RJRT scientists have recently demonstrated Eclipse is significantly less mutagenic on a per mg “tar” basis than either Carlton Soft Pack or Now Box over a wide range of machine smoking conditions. On a per cigarette basis, Eclipse was less mutagenic than Carlton Soft Pack under all machine smoking conditions tested and was less mutagenic than Now Box when evaluated using the machine smoking conditions mandated by both the Massachusetts Department of Health and the Canadian federal government. In addition, Eclipse was significantly less cytotoxic on both a per mg “tar” basis and a per cigarette basis under the same range of machine smoking conditions.7
Astonishingly, Slade et al appear to argue that these very low yielding ultra low “tar” cigarettes are the most appropriate cigarettes for the purpose of assessing the risk reduction potential of Eclipse. This argument is presumably based on the assumption that ultra low “tar” cigarettes present less risk to the smoker than the full flavour low “tar” cigarettes used in RJRT’s studies. This is contrary to the published position of the National Cancer Institute, which recently concluded that all existing tobacco burning cigarettes present equivalent risk.8
As noted by Slade et al,1 smokers typically take larger and more frequent puffs than those specified by the US Federal Trade Commission puffing regimen and they typically smoke Eclipse differently than their usual brand. Therefore, it is essential that a weight-of-the-evidence approach, including studies in smokers, be used to characterise potential differences between Eclipse and other cigarettes.3 Urine mutagenicity studies conducted in smokers demonstrate that smokers of ultra low “tar”, full flavour low “tar”, and full flavour “tar” cigarettes all experience substantial, statistically significant reductions (p < 0.05) in mutagen exposure when they switch to Eclipse.9 Furthermore, additional studies conducted in smokers have demonstrated reductions in bronchial inflammation and inflammation of the lower lung when smokers switched to Eclipse.10,11 These findings are consistent with reductions in smoker exposure to smoke constituents under actual smoking conditions and support RJRT’s conclusion that Eclipse may reduce the risks of certain smoking related diseases relative to other cigarettes currently on the market.
Swauger argues that based on the weight of the evidence, Eclipse, compared to other cigarettes, may present smokers with less risk of cancer and other smoking related diseases. He bases this conclusion on “weighing” the scientific research RJ Reynolds Tobacco (RJRT) has conducted on Eclipse. Our study drew the opposite conclusion.1 Our analysis of the Eclipse research suggests that Eclipse is as toxic or more toxic than a number of conventional cigarette brands.
RJRT claims “there is no cigarette like Eclipse” based on a comparison of the smoke chemistry of Eclipse with a typical ultralight, Merit. We tested Eclipse against two other ultralight cigarettes, Now and Carlton, and found the smoke concentrations of four major carcinogens to be similar or lower. RJRT’s claim that “there is no cigarette like Eclipse” may be misleading to consumers.
We tried to “weigh” the evidence but found that to be difficult since the control cigarettes kept changing between the studies. The smoke chemistry research used a commercial “ultralight” as a reference, the in vitro research a Kentucky “light” cigarette and the human research the “usual” brand of heavy (40 + cigarettes, per day) smokers. The “usual” brands were not identified. We also examined changes in smoke chemistry between the 1996 version of Eclipse and the 2000 version and found that concentration of four major carcinogens doubled in the 2000 version. The concentration of NNK was 1233% greater than RJRT’s early 1988 version of Eclipse called Premier.
In 2001, the Institute of Medicine’s report “Clear the Air” determined that there was insufficient evidence to conclude that any currently marketed product, including Eclipse, actually met the promise to reduce exposure to toxins or reduce harm.
Since the introduction of Eclipse, a number of other products have been brought into the market place that make explicit or implied claims of being “safer” than conventional cigarettes. These include Omni, Advance, Accord, and a soon to be released Philip Morris product called SCOR. Our article highlights the need for regulation of these products and associated claims by independent agencies such as the US Food and Drug Administration (FDA). RJRT could help “Clear the Air” by supporting pending FDA legislation. Food and drug manufacturers are not allowed to introduce new products into the market and make claims based solely on their own internal research, and nor should tobacco manufacturers. If RJRT truly believes that Eclipse may reduce risks of lung cancer and other diseases, the company should request the FDA to evaluate its scientific research and claims before marketing it at the retail level nationally.